BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO SET-BLOOD TUBING LINE

    MDR report key: 926883 · Received October 10, 2007

    Report

    Report Number
    1056186-2007-00002
    Event Type
    Injury
    Date Received
    October 10, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 7, 2007
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD (DHR): WE REVIEWED THE MANUFACTURING RECORD (TUBE EXTRUDING PROCESS, ASSEMBLING PROCESS) AND THE RESULTS OF FINAL PRODUCTS TEST AND INSPECTION REGARDING THE LOT NUMBER REPORTED, BUT WE COULD NOT FIND ANY ABNORMALITIES. EVALUATION OF RETAINED SAMPLES: VISUAL CHECK: THERE WERE NO ABNORMALITIES OBSERVED ON THE BLOOD PUMP SEGMENT SUCH AS PIN HOLE, SCRATCH AND NO HAZE AREA AT CONNECTING POINT BETWEEN BLOOD PUMP SEGMENT AND CONNECTOR. CORRECTIVE ACTION: THE CORRECTIVE ACTION IS NOT REQUIRED BECAUSE THERE WERE NO PROBLEMS ON OUR PRODUCTS. HOWEVER, TO PREVENT THIS PROBLEM, PLEASE SUGGEST THE CUSTOMER TO OBSERVE THE TUBING IS CORRECTLY LOADED IN THE BLOOD PUMP SEGMENT BEFORE START TREATMENT AND SHOULD BE MONITORED FREQUENTLY AND THE BLOOD PUMP REGULARLY CHECKED TO ENSURE THAT THE TUBING HAS NOT BECOME DISPLACED. [SEE SCANNED PAGES].

    Description of Event or Problem · 1

    APPROXIMATELY MIDWAY THROUGH A DIALYSIS TREATMENT THE BLOOD PUMP SEGMENT SPLIT OPEN AND THE PT LOST APPROXIMATELY 300CC OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO SET-BLOOD TUBING LINE BLOOD TUBING LINE FJK NIPRO MEDICAL CORPORATION A209Y/V803 07E02

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening